Annals of Long Term Care

Silodosin Rapidly Reduces BPH Symptoms in Two Studies

Chicago, IL—In two clinical studies recently conducted in the United States, treatment of benign prostatic hyperplasia (BPH) with silodosin rapidly provided significant improvement of urinary symptoms. Results of these studies were discussed in a podium session at the AUA meeting. The lead author of a post-hoc analysis of the trials was Leonard S. Marks, MD, Clinical Associate Professor in the Department of Surgery/Urology at the University of California, Los Angeles School of Medicine.

Silodosin is a highly selective alpha1A-adrenoceptor antagonist. The post-hoc analysis examined changes in International Prostate Symptom Score (IPSS) subscales by individual IPSS question. The two trials were randomized, placebo-controlled, double-blind clinical studies in men ≥ 50 years with BPH and IPSS ≥ 13. Patients enrolled in the trials were assigned to receive either silodosin or placebo.

There were 466 patients randomized to receive silodosin 8 mg and 457 patients who received placebo once daily for 12 weeks. Symptom improvement was assessed based on seven questions of the IPSS, evaluating both irritative and obstructive symptoms. IPSS scores for incomplete emptying (Q1), frequency (Q2), intermittency (Q3), urgency (Q4), weak stream (Q5), straining (Q6), and nocturia (Q7) were determined during clinical visits at baseline and weeks 1, 2, 4, and 12, and by telephone interview at day 3 or 4 of treatment.

Questions 1 to 6 were scored on a 6-point scale, from “not at all” to “almost always.” Question 7 was scored from 0 (none) to 5 (≥ 5 times). The significance of treatment effects comparing patients who received silodosin or placebo was assessed by analysis of covariance.

The authors reported that combined results of the mean baseline values for patients receiving silodosin and those receiving placebo were identical in all IPSS subcategories (Q1, 3.1; Q2, 3.5; Q3, 3.1; Q4, 3.0; Q5, 3.6; Q6, 2.2; Q7, 2.8). At the last observation, the mean change (standard deviation) in score from baseline in all IPSS subcategories was significantly greater with silodosin than with placebo. Except for Q7 (nocturia), the difference in symptom improvement between silodosin and placebo was already statistically significant at week 0.5, the earliest postbaseline measurement.

Improvement in nocturia with silodosin versus placebo was significant at week 1 of treatment (silodosin, −0.5 [1.07] vs placebo, −0.3 [1.05]; P = 0.0091). The change from baseline to the last observation for Q2 was −0.9 for the silodosin group versus −0.5 for the placebo group (P < 0.0001); for Q4, the change was −0.8 for silodosin versus −0.4 for placebo (P < 0.0001); for Q7, the change was −0.6 for silodosin versus −0.4 for placebo (P = 0.0037); for Q1, the change was −0.9 for silodosin versus −0.6 for placebo (P < 0.0001); for Q3, the change was −1.1 for silodosin versus −0.6 for placebo (P < 0.0001); for Q5 the change was −1.1 for silodosin versus −0.5 for placebo (P < 0.0001); and for Q6, the change was −0.9 for silodosin versus −0.5 for placebo (P < 0.0001).

The authors concluded that in the combined results of the two clinical trials, silodosin promoted rapid and sustained improvement in irritative and obstructive symptoms of BPH. These improvements were statistically significant after 3-7 days of treatment.

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Prebiopsy Reduction of Prostate Volume Achieved with Dutasteride

Chicago, IL—A group of researchers at a single institution has quantified treatment times needed for patients diagnosed with prostate cancer to achieve prostate volume reduction with dutasteride prior to 3-dimensional mapping biopsies (MBx). Dutasteride is a 5-alpha-reductase inhibitor. The lead author was Daniel J.